INFORMED CONSENT/ASSENT: All subjects or their legal guardians (for subjects < 18 years of age) must sign a document of informed consent (POB eligibility screening protocol) prior to performing studies to determine subject eligibility. After confirmation of subject eligibility all subjects or their legal guardians must sign the protocol-specific informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies that were performed to determine subject eligibility). Where deemed appropriate by the clinician and the child s parents or guardian, the child will also be included in all discussions about the trial and verbal assent will be obtained. The parent or guardian will sign the designated line on the informed consent attesting to the fact that the child has given assent.